Seeking an Engineer with a BS degree and 5+ years of experience in medical device product development with expertise in design controls, technical writing, and regulatory compliance.

Job Requirements:

BS Degree in Engineering

Minimum 5 years of engineering experience

Medical Device product development experience

Proficiency in DFMEA, Design Failure Modes, Design Verification & Validation (V&V), Test Method Validation (TMV), and Design Transfer

Strong technical writing skills

Knowledge of ISO 13485 and ISO 14971 standards

Experience with CAPA processes

Preferred Skills:

Experience leading design projects in regulated environments

Familiarity with risk management tools and processes

Ability to develop and validate test methods

Responsibilities:

Lead and support medical device product development projects

Conduct DFMEA and risk management activities

Develop and execute design verification and validation protocols

Author and review technical documentation to meet regulatory requirements

Manage test method validation and design transfer activities

Ensure compliance with ISO 13485 and ISO 14971 standards

Support CAPA investigations and resolution activities

Pay Details: $45.00 to $55.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.